IOGYN ENDOSCOPE

IOGYN ENDOSCOPE is an FDA 510(k)-cleared medical device (K123330) manufactured by Iogyn, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 18, 2013. Regulation: 8.